BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2850635 · Received November 29, 2012

    Report

    Report Number
    2210968-2012-07761
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION, URETHROLYSIS OF MESH, AND CYSTOSCOPY ON (B)(6) 2007. THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2007.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT VAGINAL EXTRA PERITONEAL COLPOPEXY, ANTERIOR COLPORRHAPHY, ASPIRATION OF BLADDER WITH INSERTION OF SUPRAPUBIC CATHETER AND CYSTOURETHROSCOPY DUE TO PELVIC ORGAN PROLAPSE. DUE TO URINARY RETENTION AND MESH EROSION, PATIENT UNDERWENT SLING REVISION ON (B)(6) 2007 AND REMOVAL ON (B)(6) 2012. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-07762, THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND (B)(6) 2006 AND A MESH WAS IMPLANTED. THE DATES THE MESH WAS IMPLANTED WAS NOT CLARIFIED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, UTIS AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA 1378278

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention